NCT02069743

Brief Summary

The investigators have developed a mobile application (for use on smart phones) to help cancer patients better manage cancer pain. This study is a randomized controlled trial to evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that subjects randomized to the intervention group will have a reduction in pain and pain-related hospitalizations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

4.5 years

First QC Date

February 18, 2014

Last Update Submit

June 22, 2022

Conditions

Cancer

Keywords

cancer pain

Outcome Measures

Primary Outcomes (1)

  • Pain symptoms using the Brief Pain Inventory

    The primary aim is to assess the effect of a tailored, multi-dimensional mobile-based intervention on the intensity of cancer pain in cancer patients with moderate to severe pain.

    up to 8 weeks

Secondary Outcomes (5)

  • Pain related hospitalization from the Electronic Health Record

    up to 8 weeks

  • Patient-related barriers to pain management using the Barriers Questionnaire-II

    up to 8 weeks

  • Engagement as tracked by the app

    up to 8 weeks

  • Anxiety symptoms using the Generalized Anxiety Disorder (GAD-7)

    up to 8 weeks

  • Quality of life using the Functional Assessment of Cancer Therapy (FACT-G)

    up to 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will use the study's mobile application during the 8-week study.

Other: ePAL Mobile Application

Control

NO INTERVENTION

The control group will not use the study's mobile application during the study.

Interventions

ePAL Mobile ApplicationOTHER

A mobile application designed to help cancer patients better self-manage cancer pain.

Also known as: ePAL
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients, 18 years and above suffering from solid-organ cancer.
  • Diagnosed with moderate or severe cancer pain (i.e. pain intensity score of at least 4/10 on numeric rating scale (NRS)) at the Massachusetts General Hospital (MGH) Palliative Care Center, as determined by the patient's care provider at the MGH Palliative Care Center. Subjects do not need to experience a specific nature of pain for eligibility.
  • Patients must be ambulatory and not currently admitted to the hospital at time of enrollment.
  • Must have a smart phone and be willing to download the study application (Phase II only)
  • Must be able to read and speak English.

You may not qualify if:

  • Life expectancy less than 2-months as determined by the palliative care provider
  • Significant medical or psychiatric co-morbidities (other than depression or anxiety) or cognitive impediments that would prevent participant from being able to utilize the program
  • Known history of substance abuse
  • Patients currently on investigational therapies or other study protocols that may have an impact on pain intensity or quality of life which are main outcomes of this intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Agboola S, Kamdar M, Flanagan C, Searl M, Traeger L, Kvedar J, Jethwani K. Pain management in cancer patients using a mobile app: study design of a randomized controlled trial. JMIR Res Protoc. 2014 Dec 12;3(4):e76. doi: 10.2196/resprot.3957.

    PMID: 25500281DERIVED

MeSH Terms

Conditions

NeoplasmsCancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kamal Jethwani, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 24, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2018

Study Completion

September 1, 2020

Last Updated

June 27, 2022

Record last verified: 2022-06

Locations

US(2)